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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K121248
FOIA Releasable 510(k) K121248
Device Name LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
Applicant
Moller Medical GmbH
1612 Jenks Dr.
Corona,  CA  92880
Applicant Contact GRANT GECKELER
Correspondent
Moller Medical GmbH
1612 Jenks Dr.
Corona,  CA  92880
Correspondent Contact GRANT GECKELER
Regulation Number882.5550
Classification Product Code
JXG  
Date Received04/25/2012
Decision Date 12/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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